NCT02376400

A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.

Detailed description

This is a randomized placebo-controlled, double-blind study evaluating the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at Baseline \[Day 1\] followed by a boost on Day 29 or 57 and a post-boost follow-up, until all participants have had their 21-day post-boost visit (Day 50 or Day 78). The participants who received active vaccine will enter a long-term follow-up. The total duration of the study will be about 1 year for participants who received vaccine and about 3 months for participants who received placebo. Immunogenicity and safety will be monitored during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN-Filo	One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1, 29 or 57.
BIOLOGICAL	Ad26.ZEBOV	One 0.5 mL IM injection of 5\*10\^10 viral particles (vp) on Day 1, 29 or 57.
BIOLOGICAL	Placebo	One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2016-09-01
• First posted: 2015-03-03
• Last updated: 2016-12-08

Locations

2 sites across 2 countries: Tanzania, Uganda